A phase II trial of doxorubicin and interferon alpha 2b in advanced, non-medullary thyroid cancer.

BACKGROUND

The combination of doxorubicin and interferon alpha is supported by preclinical data. We sought to evaluate the efficacy of this combination in patients with advanced thyroid cancer.

METHODS

Patients with locally recurrent or metastatic, radioiodine- refractory thyroid cancer, excluding medullary carcinoma, were treated with interferon alpha-2b 12 million units/m2 subcutaneously on days 1-5 and doxorubicin 40 mg/m2 intravenously, on day 3, every 28 days.

RESULTS

17 patients, 15 with well differentiated and 2 with anaplastic thyroid carcinoma, were enrolled; median age was 69 years. Three patients had received radiation plus low dose doxorubicin previously. In 16 patients assessable for response, 1 patient (6%), who had follicular carcinoma, achieved a partial response and 10 patients (62.5%) stable disease as best response. Median time to progression was 5.9 months and median overall survival 26.4 months. In 14 evaluable patients, 5 (36%) had a thyroglobulin response (30% or more reduction in serum levels). Grade 3/4 neutropenia occurred in 76% of patients and neutropenic fever in 24%. Other grade 3/4 adverse events included fatigue (41%), rigors (18%), fever (6%), nausea/vomiting (29%), anorexia (29%), stomatitis (24%), vision disturbances (18%), neuropathy (18%), and hyponatremia (6%). One patient developed heart failure.

CONCLUSIONS

Doxorubicin and interferon alpha was associated with considerable toxicities but modest antitumor activity in patients with advanced, non-medullary thyroid cancer.